U.S. patent application number 12/974816 was filed with the patent office on 2012-01-05 for hand held analysis device for analyzing a body fluid and a control method therefor.
Invention is credited to Thorsten Baeter, Gerhard Frisch, Wolfgang Heck, Sebastian Liedtke, Karl Miltner, Wilfried Schmid.
Application Number | 20120004852 12/974816 |
Document ID | / |
Family ID | 39726395 |
Filed Date | 2012-01-05 |
United States Patent
Application |
20120004852 |
Kind Code |
A1 |
Miltner; Karl ; et
al. |
January 5, 2012 |
HAND HELD ANALYSIS DEVICE FOR ANALYZING A BODY FLUID AND A CONTROL
METHOD THEREFOR
Abstract
A method is provided for controlling a hand-held analysis device
for analyzing a body fluid in which in each case at least one test
means for single use is automatically provided in consecutive
measuring cycles by means of a control device where each measuring
cycle in a measuring mode of the control device is triggered by a
start actuation. According to the invention it is proposed that a
defined control intervention puts the control device into a
maintenance mode in which the automatic provision of a test means
is prevented.
Inventors: |
Miltner; Karl; (Frankenthal,
DE) ; Baeter; Thorsten; (Warszawa, PL) ;
Frisch; Gerhard; (Edingen-Neckarhausen, DE) ;
Liedtke; Sebastian; (Heidelberg, DE) ; Schmid;
Wilfried; (Mannheim, DE) ; Heck; Wolfgang;
(Frankenthal, DE) |
Family ID: |
39726395 |
Appl. No.: |
12/974816 |
Filed: |
December 21, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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PCT/EP2009/057666 |
Jun 19, 2009 |
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12974816 |
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Current U.S.
Class: |
702/19 |
Current CPC
Class: |
G01N 33/48764 20130101;
G01N 35/00009 20130101 |
Class at
Publication: |
702/19 |
International
Class: |
G06F 19/00 20110101
G06F019/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 25, 2008 |
EP |
08158943.4 |
Claims
1. A method for controlling a hand-held analysis device for
analyzing a body fluid, the device comprising an electronic control
device configured to automatically provide at least one test means
for a single use in consecutive measuring cycles when the control
device is in a measuring mode, each measuring cycle being triggered
by a start actuation, the test means comprising a wound test tape,
the method comprising the step of: putting the control device into
a maintenance mode by a defined control intervention, wherein the
automatic provision of a test means is suspended during the
maintenance mode so that the automatic provision of the test means
in the hand-held analysis device is prevented.
2. The method according to claim 1, further wherein the start of a
measuring cycle is blocked during the maintenance mode even in the
case of a start actuation.
3. The method according to claim 1, wherein the device can be
cleaned or test means can be exchanged in the maintenance mode
without a loss of test means.
4. The method according to claim 1, wherein putting the control
device into the maintenance mode is performed by selecting the
maintenance mode via a software menu of the electronic control
device.
5. The method according to claim 1, wherein putting the control
device into the maintenance mode is performed by manually
activating a switch comprising a softkey.
6. The method according to claim 1, wherein the start actuation
comprises a predetermined operation of a component of the analysis
device, said operation being recognized by the control device.
7. The method according to claim 1, wherein at least one of the
start actuation and an exchange of test means is monitored by a
sensor provided in the analysis device, wherein the sensor signal
is ignored when the control device is put in the maintenance
mode.
8. The method according to claim 1, wherein the test means are
protected in a housing of the hand-held analysis device against
environmental influences.
9. The method according to claim 1, wherein the start actuation for
a measuring cycle comprises opening a protective cover of the
hand-held analysis device whereupon a test means is provided for
access by the user.
10. The method according to claim 1, wherein during the measuring
mode the test means are automatically transported by a transport
device to at least one predetermined position and the automatic
transport of test means is suspended during the maintenance
mode.
11. The method according to claim 1, wherein the respective test
means are transported from a store of test means to an application
site and transported to a test means waste during a measuring
cycle.
12. The method according to claim 1, wherein a test tape furnished
with a plurality of analytical test fields as test means is used
and the test tape is wound up in sections in order to provide the
test means.
13. The method according to claim 1, wherein the test means can be
exchanged in a compartment of the device, the test means having the
form of a magazine or a cassette, the test means being activated by
a start actuation and discarded during the measuring mode when the
compartment of the device is opened.
14. A hand-held analysis device for analyzing a body fluid,
comprising an electronic control device for automatically providing
test means designed for single use in consecutive measuring cycles
where each measuring cycle can be triggered in a measuring mode of
the control device by a start actuation and where a test tape is
wound up in sections in order to provide the test means, wherein
the control device can be put into a maintenance mode by a defined
control intervention, in which maintenance mode the automatic tape
transport is suspended, such that the automatic provision of a test
means in the hand-held analysis device is prevented.
Description
CLAIM OF PRIORITY
[0001] The present application is a continuation application based
on and claiming priority to PCT/EP2009/057666, filed Jun. 19, 2009,
which claims the priority benefit of European Patent Application
No. 08158943.4, filed Jun. 25, 2008, each of which are hereby
incorporated by reference in their respective entireties.
TECHNICAL FIELD OF THE INVENTION
[0002] The present application relates to a method for controlling
a hand-held analysis device for analyzing a body fluid, and more
particularly to such a device in which in each case at least one
test means for single use is automatically provided in consecutive
measuring cycles by means of a control device implemented in the
analysis device, wherein with the control device in a measuring
mode, a measuring cycle is triggered by a start actuation. The
present application additionally concerns a hand-held analysis
device for analyzing blood sugar.
BACKGROUND
[0003] Methods have been disclosed in which individual test strips
are supplied from an exchangeable drum magazine for analytical
purposes. Consumption of the individual test strips is recorded by
the device by assigning a counter reading to a magazine identifier
and is not written back onto the magazine thus also simplifying the
optional use of partially used magazines. See, for example, a
system such as is disclosed in EP-A 1 770 395.
[0004] In order to further increase the system integration, in
other disclosures it has been proposed to use a spooled test tape
with analytical test fields that are spaced apart as test means in
a hand-held device instead of individual strips. Marker areas which
allow an exact positioning of the test fields are provided in this
case to register the distance travelled during tape transport. With
such concepts it is particularly challenging to minimize the
overall size and the number of required operating steps. See, for
example, a system such as is disclosed in EP-A 1 739 432.
[0005] The object of the invention is to further develop the
methods and products known in the prior art and to increase the
user-friendliness and reliability of the methods using simple means
also with regard to an optimized utilization of the test means.
SUMMARY
[0006] This object and others that will be appreciated by a person
of ordinary skill in the art have been achieved according to the
embodiments of the present invention disclosed herein, including
those set forth in the claims.
[0007] It has been noted by the inventors that the provision of an
analytical test means in a hand-held device cannot usually be
retracted without diminishing the test quality. This problem is
comparable with conventional film cameras which should not simply
be opened when a film has been placed in them. In order to achieve
the object of the present invention, in one embodiment, the present
invention comprises a defined control intervention that puts the
device-implemented program-controlled control device into a
maintenance mode in which the automatic provision of a test means
inserted into the device is prevented. In this manner an
unintentional test loss is avoided without impairing the handling
in a normal measuring process.
[0008] In one embodiment, a method is performed for controlling a
hand-held analysis device for analyzing a body fluid, the device
comprising an electronic control device configured to automatically
provide at least one test means for a single use in consecutive
measuring cycles when the control device is in a measuring mode,
each measuring cycle being triggered by a start actuation, the test
means comprising a wound test tape, the method comprising the step
of putting the control device into a maintenance mode by a defined
control intervention, wherein the automatic provision of a test
means is suspended during the maintenance mode so that the
automatic provision of the test means in the hand-held analysis
device is prevented.
[0009] The start of a measuring cycle is blocked in the maintenance
mode even in the case of a start actuation. This allows handling
steps to be carried out which in the measuring mode would have led
to a start of a measurement.
[0010] The maintenance mode is established to enable the device to
be cleaned or to allow an exchange of test means or an intermittent
removal of the test means out of the device without loss of test
means due to an unintentional test provision.
[0011] In order to reduce the constructional complexity, in one
embodiment the maintenance mode is selected by a user via a
software menu of the electronic control device. This can be
achieved in a particularly simple manner when the maintenance mode
is initiated by a manually operated switch such as a softkey
provided on the device.
[0012] In another embodiment, a predetermined operation of a device
component is recognized by the control device as a start actuation.
This allows the number of required operating steps to be reduced
and achieves a rapid availability. In further refinements, the
start actuation and/or an exchange of test means is monitored by a
sensor, and the sensor signal is ignored when the control device is
in the maintenance mode.
[0013] In other embodiments, the test means are protected in a
housing of the hand-held analysis device against environmental
influences such as moisture in order to ensure a high degree of
reliability.
[0014] In yet other embodiments, improved operating friendliness is
achieved when measuring cycles are configured to be triggered by
the opening of a protective cover of the hand-held analysis device
whereupon a test means is provided for access by the user.
[0015] In embodiments in which test means stored in magazines are
used, one refinement when in the measuring mode provides that the
test means are transported by a transport device to at least one
predetermined position and when the automatic transport of test
means is suspended in the maintenance mode. According to a further
refinement the respective test means is transported from a store of
test means to an application site and optionally to a test means
waste during a measuring cycle.
[0016] Embodiments of the present invention can be used for example
in connection with using a test tape furnished with a plurality of
analytical test fields and/or lancing elements as test means and
winding on the test tape in sections in order to provide the test
means. A further refinement provides that the test means can be
exchanged in a compartment of the device such as in the form of a
magazine or cassette, and that a test means activated by a start
actuation is discarded in the measuring mode when the compartment
of the device is opened.
[0017] The present invention also concerns a device for carrying
out the method, comprising a control device configured for
automatically providing test means designed for single use in
consecutive measuring cycles where each measuring cycle can be
triggered in a measuring mode of the control device by a start
actuation and where a defined control intervention can put the
control device into a maintenance mode in which the automatic
provision of a test means is prevented.
[0018] The present invention is to be explained in more detail by
the following figures and examples.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The following detailed description of the embodiments of the
present invention can be best understood when read in conjunction
with the following drawings, where like structure is indicated with
like reference numerals and in which:
[0020] FIG. 1 shows a perspective view of a portable blood sugar
measuring device configured for use with a test tape cassette.
[0021] FIG. 2 shows the measuring device according to FIG. 1 in a
longitudinal section.
[0022] FIG. 3 shows a flow diagram to illustrate one embodiment of
a process employing the measuring mode and maintenance mode of the
blood sugar measuring device of the present invention.
[0023] In order that the present invention may be more readily
understood, reference is made to the following detailed
descriptions and examples, which are intended to illustrate the
present invention, but not limit the scope thereof.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION
[0024] The following descriptions of the embodiments are merely
exemplary in nature and are in no way intended to limit the present
invention or its application or uses.
[0025] The portable blood sugar measuring device 10 shown in FIGS.
1 and 2 allows a user to determine his own blood sugar level on the
spot in a substantially automated measuring process. In this
connection a plurality of analytical test means in the form of a
tape cassette 12 as an exchangeable disposable can be inserted into
the compact device housing 14 in order to carry out a corresponding
number of tests without complicated handling. For the device
maintenance it is possible to prevent an unintentional loss of test
means by an advantageous process control by means of an electronic
control device 16 of the device 10 provided with a control
software.
[0026] As shown in FIG. 1 various control buttons 18, 20 are
arranged on the top side of the housing 14 for manual actuation. A
screen 22 enables operating menus 24 and measurement results to be
displayed. The tape cassette 12 protected in the housing 14 is
accessible at an application site for the application of a blood
sample by opening a protective cover 26. A lancing aid (not shown)
for collecting the blood sample can be flange-mounted on a holder
28 at the side of the housing 14.
[0027] FIG. 2 shows a section through the interior of the device
with an inserted tape cassette 12, control device (circuit board
16), tape drive unit 30, measuring unit 31 and energy supply
(batteries 32). The cassette 12 stored in the cassette compartment
34 can be exchanged as a consumable article via a cover 36 at the
bottom of the housing. The position of the various device access
points is registered by sensors as shown for the protective cover
26 as an example by the switch 37.
[0028] The cassette 12 comprises a test tape 38, a supply spool 40
which is sealed towards the outside for unwinding unused test tape
and a take-up spool 42 to wind on used test tape. Test fields 44
coated with a test chemistry are mounted spaced apart from one
another on the test tape 38 as test means for detecting the analyte
(e.g., glucose). Alternatively or in addition it is also possible
to store lancing elements that are not shown on a carrier tape for
a skin puncture. The test tape 38 can be wound forwards by means of
the drive unit 30 such that the test units 20 can be provided
successively at an application site 46 for applying the blood
sample, where said application site (46) is uncovered by swinging
back the protective cover 26. A glucose measurement value can then
be obtained by a reflectometric measurement from the rear side of
the test field 44 to which blood has been applied on the basis of a
color change.
[0029] The process control shown in FIG. 3 uses simple measures to
enable an alternative mode between measuring and maintenance while
reducing the number of required operating steps and user actions
whereby a loss of test means is largely avoided.
[0030] As shown in the left part of the diagram in FIG. 3, a
measuring cycle can be started by the user by opening the tip
protection (protective cover 26) without the need to operate
additional start buttons. This ensures a very rapid availability of
the system. The menu selection "measuring" can, however, also be
selected via the operating buttons 18, 20 as an alternative start
actuation.
[0031] The unused test fields 44 remain screened against
environmental influences such as light, humidity and dirt on the
supply spool 40 that is screened towards the outside until the
measuring cycle is started. The positioning of the test fields at
the application site 46 is then controlled by a tape transport in
which control marks applied to the test tape 38 are registered
during an initialization phase in order to enable a defined tape
advance. In this case the possibility of winding back is not
provided due to the complication of the apparatus and could lead to
undefined states of the test means. Subsequently blood is applied
to the test field 44 positioned above the measuring tip as the next
user action. Then a measurement result obtained by means of the
measuring unit 31 can be displayed on the display 22. The measuring
cycle is ended in a simple manner by the user by closing the tip
protection 26 whereupon the used test field 44 is disposed of on
the take-up spool 42 by further tape transport and the device is
switched off. Such a measuring cycle can be repeated until all
stored test fields 44 are used before a cassette replacement is
necessary.
[0032] If in the measuring mode an unscheduled but monitored device
access occurs and in particular if the cassette compartment 34 is
opened, the control device discards the current test for safety
reasons in order to exclude a possible falsification of the
measured value. In this case it must be borne in mind that the
device must also be designed to be operated by laymen and that a
false measurement result can lead to serious false diagnoses.
[0033] This must be differentiated from a necessary access to the
inside of the device in order to clean it or to fulfill other
service functions or for demonstration purposes. In such a case a
disadvantageous loss of a test means or test field 44 should be
avoided. For this purpose the control device can be put into a
maintenance mode by a defined control intervention as shown in the
right part of the diagram of FIG. 3.
[0034] The control intervention is realized by the menu point
"clean" of a software menu which the user can simply select by the
operating key 20. This key is designed as a "softkey" and can thus
execute different functions depending on a screen display.
[0035] As soon as the operating mode has been initiated, the sensor
signals which occur when the tip protection 26 or the cassette
compartment 34 are opened, are ignored or no longer interpreted as
a start actuation so that an automatic tape transport no longer
occurs. Thus the start of a measuring cycle is blocked and an
unintentional loss of test means is prevented.
[0036] The user can then be prompted to carry out certain actions
via the screen 22. After the tip protection 26 and the cassette
compartment cover 36 are opened, the device is switched off. The
user can remove the cassette 12, clean the interior of the device
and in particular the measuring optics 31, replace the cassette and
reclose the cassette compartment and tip protection. The device 10
is then on standby for the measuring mode.
[0037] The features disclosed in the above description, the claims
and the drawings may be important both individually and in any
combination with one another for implementing the invention in its
various embodiments.
[0038] It is noted that terms like "preferably", "commonly", and
"typically" are not utilized herein to limit the scope of the
claimed invention or to imply that certain features are critical,
essential, or even important to the structure or function of the
claimed invention. Rather, these terms are merely intended to
highlight alternative or additional features that may or may not be
utilized in a particular embodiment of the present invention.
[0039] For the purposes of describing and defining the present
invention it is noted that the term "substantially" is utilized
herein to represent the inherent degree of uncertainty that may be
attributed to any quantitative comparison, value, measurement, or
other representation. The term "substantially" is also utilized
herein to represent the degree by which a quantitative
representation may vary from a stated reference without resulting
in a change in the basic function of the subject matter at
issue.
[0040] Having described the present invention in detail and by
reference to specific embodiments thereof, it will be apparent that
modification and variations are possible without departing from the
scope of the present invention defined in the appended claims. More
specifically, although some aspects of the present invention are
identified herein as preferred or particularly advantageous, it is
contemplated that the present invention is not necessarily limited
to these preferred aspects of the present invention.
* * * * *